ClearanceBrief
Panels › General, Plastic Surgery › Product code KGO · Class 1

Surgeon'S Gloves

Regulation 878.4460

2510(k)s in 12 months (560 all time)
1recalls in 12 months (44 all time)
43recalls that name a 510(k)
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Top companies in KGO

Company510(k)sRecalls
Ansell Healthcare Products, Inc.1612
Cardinal Health, Inc.138
Wrp Asia Pacific Sdn. Bhd.201
Cardinal Health 200, Inc.117
Terang Nusa Sdn Bhd152
Molnlycke Health Care Us, LLC160
Ansell Perry150
Wembley Rubber Products (M) Sdn Bhd150
Medline Industries, Inc.122
Johnson & Johnson Medical, Inc.100
Decided510(k)Device and applicantCode
Mar 13, 2020K191869Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Unde
Molnlycke Health Care Us, LLC
KGO
Mar 10, 2020K192328JR.MEDIK Latex Surgeon’s Gloves Powder Free
Jr Engineering & Medical Technologies (M) Sdn. Bhd., MY
KGO
Mar 6, 2020K191915SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V
Medline Industries, Inc.
KGO
Feb 28, 2020K192820SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)
Medline Industries, Inc.
KGO
Dec 30, 2019K190241Sterile Latex Surgical Glove, Powder Free
Careglove Global Sdn. Bhd., MY
KGO
Dec 18, 2019K191898Sterile Latex Powder-Free Surgical Gloves
Modern Healthcare Corp., TW
KGO
Oct 24, 2019K190632Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable prot
Lenora Glove Pvt , Ltd., IN
KGO
Aug 16, 2019K183536Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
Hartalega NGC Sdn. Bhd., MY
KGO
Jun 28, 2019K183389Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove
Hartalega NGC Sdn. Bhd., MY
KGO
Jun 27, 2019K190782FlexGard Cut-Resistant Glove Liners
Ldi Corporation
KGO
May 24, 2019K190077Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove
Molnlycke Health Care Us, LLC
KGO
May 23, 2019K190018Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
Ansell Healthcare Products, LLC
KGO
Mar 28, 2019K182176Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs
Pt. Medisafe Technologies, ID
KGO
Mar 22, 2019K182948Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
Ansell Healthcare Products, LLC
KGO
Jan 9, 2019K181047Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs
Smart Glove Corporation Sdn. Bhd., MY
KGO
Aug 8, 2018K180221Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs
Smart Glove Corporation Sdn. Bhd., MY
KGO
Jul 13, 2018K171550Sterile Latex Surgical Gloves, Powder Free
Sanrea Healthcare Products Pvt, Ltd., IN
KGO
Apr 30, 2018K173304Finessis Intense Polyisoprene Surgical Glove
Lucenxia Prescience AG, CH
KGO
Apr 20, 2018K173258Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy
Pt. Medisafe Technologies, ID
KGO
Apr 9, 2018K173386Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs
Lucenxia Prescience AG, CH
KGO
Feb 6, 2018K171375Gammex PI Breach Detect Powder Free Surgical Glove
Ansell Healthcare Products, LLC
KGO
Jan 8, 2018K172942Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less pe
Beta Healthcare Products Pvt., Ltd., IN
KGO
Oct 20, 2017K171987Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
Lucenxia Prescience AG, CH
KGO
Oct 12, 2017K171279Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Fre
Top Glove Sdn. Bhd., MY
KGO
Sep 29, 2017K172420Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic La
Wear Safe (Malaysia) Sdn. Bhd., MY
KGO
Aug 21, 2017K171276Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs
Tg Medical Sdn. Bhd., MY
KGO
Aug 18, 2017K171898Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs
Better Care Plastic Technology Co., Ltd., CN
KGO
Jun 22, 2017K171047Sterile Polyisoprene Powder Free Surgical Gloves
Better Care Plastic Technology Co., Ltd., CN
KGO
Jun 15, 2017K170198Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
Cardinal Health, Inc.
KGO
Jun 9, 2017K170515Sterile Nitrile Surgical Gloves, Powder-free
Primus Gloves Pvt Limited, IN
KGO
May 5, 2017K170152POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
Hartalega Sdn Bhd, MY
KGO
May 2, 2017K160781Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
Semperit Investments Asia Pte , Ltd., SG
KGO
Feb 8, 2017K162852Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove
Lucenxia Prescience AG, CH
KGO
Jan 23, 2017K161823Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs
Wrp Asia Pacific Sdn. Bhd., MY
KGO
Dec 20, 2016K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (N
Hartalega Sdb. Bhd., MY
KGO
Oct 28, 2016K160974Gammex Cut-Resistant Glove Liner
Ansell Healthcare Products, LLC
KGO
Jul 28, 2016K161008POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE
Hartalega Sdn Bhd, MY
KGO
Jul 11, 2016K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
Cardinal Health, Inc.
KGO
May 12, 2016K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy D
Cardinal Health, Inc.
KGO
Mar 31, 2016K152428SensiCare PI Surgical Gloves
Medline Industries, Inc.
KGO
Mar 24, 2016K151778Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
Cardinal Health 200, Inc.
KGO
Mar 9, 2016K151694Gammex PI Hybrid Surgical Gloves
Ansell Healthcare Products, LLC
KGO
Jan 15, 2016K151228PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm
Emerson & Co. Srl, IT
KGO
Dec 11, 2015K151114Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with
St. Marys Rubbers Pvt, Ltd., IN
KGO
Nov 27, 2015K150238SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherap
Medline Industries, Inc.
KGO
Nov 16, 2015K151607Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
Lucenxia Prescience AG, CH
KGO
Nov 16, 2015K151605Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves
Lucenxia Prescience AG, CH
KGO
Nov 16, 2015K150609Annuy Latex Surgeon's Gloves (Powdered and Powder Free)
Anhui Anyu Latex Products Co., Ltd., CN
KGO
Nov 2, 2015K142941Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Poly
Pt. Medisafe Technologies, ID
KGO
Sep 18, 2015K151392Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less
Terang Nusa Sdn Bhd, MY
KGO

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